Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.

NCT04413929 | Completed Results

• 1 other identifier: HERMITAGE
• Study Type: observational
• Target: 8,411
• Locations: 0 countries
• Sites: N/A

Brief Summary

The observational study to get the additional data of the safety and effectiveness of Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.

Conditions

Viral Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Duration of Influenza/ARVI Symptoms.

  The time from the onset of treatment with Ergoferon to the resolution of the symptoms, i.e. a body temperature ≤37.0 °С remaining at this level for 24 h (with no further increases throughout the rest of the observation period) in the absence of catarrhal signs and systemic symptoms. Based on Case Report Form data.

  through study completion up to 1 month

Secondary Outcomes (5)

• Duration of Increased Body Temperature.

  through study completion up to 1 month

• Duration of Systemic Symptoms.

  through study completion up to 1 month

• Duration of Nose Symptoms.

  through study completion up to 1 month

• Duration of Throat Symptoms.

  through study completion up to 1 month

• Percentage of Patients With Complications of Influenza/Acute Viral URI.

  through study completion up to 1 month

Study Arms (1)

Ergoferon

Oral administration in the therapeutic dosage specified in the instructions for medical use.

Drug: Ergoferon

Interventions

Ergoferon DRUG

Oral administration

Ergoferon

Eligibility Criteria

• Age: 6 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children from 6 months to 18 years of age and adults over 18 years of age in any gender and demographic proportion.

You may qualify if:

• Data of children from 6 months to 18 years old and adults over 18 years old.
• Diagnosis: Flu / ARVI.
• Axillary temperature above 37.4 °С.
• At least one systemic and/or catarrhal symptom lasting 12 hours to 3 days by the time the doctor is consulted, for which treatment with Ergoferon is prescribed.
• A specific decision of the doctor to prescribe Ergoferon in strict accordance with the indications, regardless of the factor of including patient data in the program.
• CRF, filled by a doctor on the basis of medical documentation, at the end of patient observation.

You may not qualify if:

• Not applicable.

Sponsors & Collaborators

• Materia Medica Holding: lead

MeSH Terms

Interventions

ergoferon

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: MATERIA MEDICA HOLDING

PutilovskiyMA@materiamedica.ru

+74952761571

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 2, 2021
• Results First Posted: April 2, 2021

Record last verified: 2020-05